Absorica (Page 2 of 11)

2.3 Laboratory Testing Prior to Administration

The following laboratory testing must be completed prior to ABSORICA/ABSORICA LD use:

Pregnancy testing: Ensure patient is not pregnant prior to administering ABSORICA/ABSORICA LD [see Contraindications (4) and Use in Specific Populations (8.1, 8.3)]
A fasting lipid profile including triglycerides [see Warnings and Precautions (5.8, 5.15)].
Liver function tests [see Warnings and Precautions (5.10, 5.15)].

3 DOSAGE FORMS AND STRENGTHS

ABSORICA and ABSORICA LD have different dosage regimens [see Dosage and Administration (2.1)]. Although ABSORICA and ABSORICA LD have a 20 mg strength, these strengths have different bioavailability and are not substitutable.

ABSORICA is available in 10 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg capsules.

10 mg: Dark yellow, opaque, capsule imprinted with black ink “G 240 ” on cap and “10 ” on the body
20 mg: Red, opaque, capsule imprinted with black ink “G 241 ” on cap and “20 ” on the body
25 mg: Green, opaque, capsule imprinted with white ink “G 342 ” on cap and “25 ” on the body
30 mg: Brown, opaque, capsule imprinted with white ink “G 242 ” on cap and “30 ” on the body
35 mg: Dark blue, opaque, capsule imprinted with white ink “G 343 ” on cap and “35 ” on the body
40 mg: Brown and red, capsule imprinted with white ink “G 325 ” on cap and “40 ” on the body

ABSORICA LD is available in 8 mg, 16 mg, 20 mg, 24 mg, 28 mg and 32 mg opaque-printed, hard-gelatin capsules.

8 mg: A size 3, light green with a colorless band (the cap is printed in white with “RL29” and the body is printed in white with “RL29 ”).
16 mg: A size 2, dark blue with a colorless band (the cap is printed in white with “RL30” and the body is printed in white with “RL30 ”).
20 mg: A size 1, dark pink with a colorless band (the cap is printed in black with “RL33”and the body is printed in black with “RL33 ”).
24 mg: A size 1, yellow with a colorless band (the cap is printed in white with “RL31” and the body is printed in white with “RL31 ”).
28 mg: A size 0, light blue, with a colorless band (the cap is printed in black with “RL34” and the body is printed in black with “RL34 ”).
32 mg: A size 0, caramel with a colorless band (the cap is printed in white with “RL32” and the body is printed in white with “RL32 ”).

4 CONTRAINDICATIONS

4.1 Pregnancy

ABSORICA/ABSORICA LD is contraindicated in pregnancy [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)].

4.2 Hypersensitivity

ABSORICA/ABSORICA LD is contraindicated in patients with hypersensitivity to isotretinoin (or Vitamin A, given the chemical similarity to isotretinoin) or to any of its components (anaphylaxis and other allergic reactions have occurred) [see Warnings and Precautions (5.14)].

5 WARNINGS AND PRECAUTIONS

5.1 Embryo-Fetal Toxicity

ABSORICA/ABSORICA LD is contraindicated in pregnancy [see Contraindications (4.1)]. Based on human data, ABSORICA/ABSORICA LD can cause fetal harm when administered to a pregnant patient. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking any amount of ABSORICA/ABSORICA LD even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining prenatally whether an exposed fetus has been affected. Major congenital malformations, spontaneous abortions, and premature births have been documented following exposure to isotretinoin during pregnancy [see Use in Specific Populations (8.1)].

If a pregnancy occurs during ABSORICA/ABSORICA LD treatment, discontinue ABSORICA/ABSORICA LD immediately and refer the patient to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling. Any suspected fetal exposure during or 1 month after ABSORICA/ABSORICA LD therapy must be reported immediately to the FDA via the MedWatch telephone number 1-800-FDA-1088, and also to the iPLEDGE pregnancy registry at 1-866-495-0654 or via the internet (www.ipledgeprogram.com).

Patients must be informed not to donate blood during ABSORICA/ABSORICA LD therapy and for 1 month following discontinuation because the blood might be given to a pregnant patient whose fetus must not be exposed to isotretinoin.

ABSORICA/ABSORICA LD is available only through a restricted program under a REMS [see Warnings and Precautions (5.2)].

5.2 iPLEDGE Program

ABSORICA/ABSORICA LD are available only through a restricted program under a REMS called the iPLEDGE REMS because of the risk of embryo-fetal toxicity [see Warnings and Precautions (5.1)]. Notable requirements of the iPLEDGE REMS include the following:

Prescribers must be certified with the program and comply with the following requirements:
Determine reproductive status of all patients prior to initiating treatment
Provide contraception counseling to patients who can get pregnant prior to and during treatment, or refer patients who can get pregnant to an expert for such counseling
Provide scheduled pregnancy testing, and verify and document the negative pregnancy test result prior to writing each prescription, for no more than a 30-day supply
Patients who can become pregnant must be enrolled by signing an informed consent form and must comply with the following requirements
Comply with the pregnancy testing and contraception requirements [see Use in Specific Populations (8.3)]
Demonstrate comprehension of the safe-use conditions of the program every month
Obtain the prescription within 7 days of the pregnancy test collection
Patients who cannot become pregnant must be enrolled by signing an informed consent form and must obtain the prescription within 30 days of the office visit
Pharmacies that dispense ABSORICA/ABSORICA LD must be certified by being registered and activated in the program, must only dispense to patients who are authorized to receive ABSORICA/ABSORICA LD, and comply with the following requirements:
Only dispense a maximum of a 30-day supply with a Medication Guide.
Do not dispense refills. Dispense only with a new prescription and a new authorization from the program.
Return ABSORICA/ABSORICA LD to inventory if patients do not obtain the prescription by the “Do Not Dispense To After ” date
Wholesalers and distributors must be registered with the program and must only distribute to certified pharmacies.

Further information, including a list of qualified pharmacies and distributors, is available at www.ipledgeprogram.com or 1-866-495-0654.

5.3 ABSORICA and ABSORICA LD are Not Substitutable

Given that the bioavailability and the recommended dosage of ABSORICA and ABSORICA LD are different, ABSORICA and ABSORICA LD are not substitutable. For example, ABSORICA and ABSORICA LD have a 20 mg strength; however, these strengths have different bioavailability and are not substitutable.

5.4 Psychiatric Disorders

ABSORICA/ABSORICA LD may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts, suicide, and aggressive and/or violent behaviors [see Adverse Reactions (6)].

Healthcare providers should be alert to the warning signs of psychiatric disorders to help ensure patients receive the help they need (Prescribers should read the brochure, Recognizing Psychiatric Disorders in Adolescents and Young Adults: A Guide for Prescribers of Isotretinoin). Prior to initiation of ABSORICA/ABSORICA LD therapy, patients and family members should be asked about any history of psychiatric disorder, and at each visit during therapy patients should be assessed for symptoms of depression, mood disturbance, psychosis, or aggression to determine if further evaluation is necessary.

Patients should immediately stop ABSORICA/ABSORICA LD and the patient (or caregiver) should promptly contact their prescriber if the patient develops depression, mood disturbance, psychosis, or aggression. Discontinuation of ABSORICA/ABSORICA LD may be insufficient; further evaluation may be necessary such as a referral to a mental healthcare professional.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.